Resources – Quality




Chris Bouchee — Medical Engineering Consultants (MEC)

Medical Engineering Consultants (MEC) is a consulting and training firm that provides services that cover design and development, quality management systems (QMS), manufacturing, and regulatory submissions.  These services range from individual contributors to full scoping, staffing and execution of small or large scale projects.  Our founders are industry veterans with over 40 years’ experience in R&D, Operations, Quality and Regulatory roles and truly understand your individual project needs.

Please get in touch to discuss your consulting, contracting or training needs!

  • Design Controls – Design Verification and Validation
  • QMS Implementation, Gap Assessments and Closure
  • Project Management – Custom Tailored to your needs
  • Regulatory Pathways – Submission Type and Strategy
  • Training and Organizational Change Management

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Mike Cremeans — Life Sciences Practice Leader

Top Five Areas of Expertise 

  1. Subject Matter Expert in Insurance and Risk Management in Multiple Industries
    • FDA-Regulated (e.g., med device, med-tech, pharma, biotech)
    • Highly Innovative (e.g., AI, remote healthcare solutions, SaaS)
  1. Worldwide Knowledge and Expertise:
    • Clinical trials
    • Insurance
    • Risk issues
  1. Enterprise Business Risk Evaluation:
    • Identify risks that will impact strategic objectives
    • Develop an actionable approach to implementing risk transfer (insurance) and mitigation  programs (contractual reviews)
    • Provide executive-level reporting to Board 
  1. Insurable Risk Optimization:
    • A complete audit of your portfolio’s insurance suite
    • Match contractual obligations to the insurance portfolio. “Look under the tent” to assure  the policies cover the “ship sinkers.”
    • Establish controls for verification of third-party risk transfer mechanisms (e.g., contracts)
    • Help develop detailed submissions for the insurance market – provide a clear view of the  risks and exposures to loss
    • Benchmark your current program and develop a methodology to assure future exposures  are covered
    • Reduce the Impact of an uncovered claim 
  1. Problem Solver and Connector:
    • An expansive, world-class network of professionals (finance, PEO, HR, regulatory,  quality, AI, legal, marketing, product development) FDA-focused
    • Connected at the highest levels of all major insurance providers

Additional Services 

  1. Help and support the portfolio to prepare for scaling the business or exit. A well-executed risk  management plan and appropriate insurance portfolio can improve valuations. (think: Importance of Quality Management Systems). We’ve guided IPOs.

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George Martinez — ICON

ICON is the first medical device training center specializing in manufacturing and R&D. We offer hands-on training for your incoming or current employees on the essential tools and techniques used in the medical device field. Our goal is to have your employees familiar with the tools and processes you require when they enter your production area.  With professionally trained employees, quality increases and rejects and scrap decreases. We offer custom courses specifically designed to meet your needs. ICON can also assist with process transfers and process development. At ICON we are dedicated to helping you provide quality products to your customers.

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Kristin Mortenson — Nirin Inc.

The foundation for bringing medical products to market began with a Bachelor of Mechanical Engineering, from the University of Minnesota Twin Cities, and continues to this day with ~30 years of industry experience and continuing education. The combined experience bridges across Research, Design, Development, Quality, and Regulatory through a broad range of products and companies ranging from small to large multi-national. Specializing in start ups, and using project management practices for product development, utilizing design control steps and integrated risk management.

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Anne Quinlan-Smith

Is the Sr. Vice President of Quality, Regulatory and Clinical Affairs at Surgical Information Sciences. Anne is an experienced Division President with a demonstrated history of working in the medical device industry. She is a strong business development professional skilled in U.S. Food and Drug Administration (FDA), Clinical Research, Medical Devices, Life Sciences, and CRO Management. Anne understands corporate goals to plan practical regulatory strategies, and has experience developing clinical study designs to collect clinical evidence and reimbursement data supportive of regulatory and reimbursement strategies. She can help you budget for clinical, regulatory and quality costs and prepare for meetings with Regulatory Agencies.

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